DefenCath NDA to be Resubmitted by Mid-May

CorMedix says that following a meeting with FDA, it plans to resubmit its NDA for DefenCath by mid-May. A company statement says that at the meeting, FDA indicated it had received the close-out report for inspectional observations at the CorMedix contract manufacturing organization and the NDA could be resubmitted. The company says the resubmitted NDA will have manufacturing data generated from the contract manufacturer and will use an existing source of heparin active pharmaceutical ingredient (API) and a new heparin API supplier.

DefenCath is described as a novel, non-antibiotic antimicrobial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with using central venous catheters in patients undergoing chronic hemodialysis. FDA has given it Fast Track and Qualified Infectious Disease Product designations. The company says the original NDA received priority review in recognition of its potential to address an unmet medical need.